The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Megabeam Fiber Optic Delivery System.
| Device ID | K946336 |
| 510k Number | K946336 |
| Device Name: | MEGABEAM FIBER OPTIC DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-29 |
| Decision Date | 1995-02-10 |